Many Quality Engineers join the workforce with technical understanding of the products without the statistical understanding of product variability. The FDA's findings of deficiencies concerning sample size, gage studies, statistical process control and other statistical issue indicate the agencies expect definitive evidence that statistics are properly applied. Case studies and example from FDA 483 findings will be presented.
The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations?
In this two day workshop conference you will learn the different statistical tools necessary to comply with global agencies expectations. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. Additionally, case studies will explore how your management practices can help or hurt your liability that arises from nonconformance with regulators and Auditors.
Upon completing this course participants should:
This course is designed for quality professionals tasked with developing, maintaining and/or improving products and/or processes. This includes individuals that have Quality Management Systems responsibilities for making general improvements in their organization's performance. Following personnel will benefit from the course:
Steven Walfish , is the President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to FDA regulated industries. Prior to starting Statistical Outsourcing Services, Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD. Prior to joining HGS, Mr. Walfish was a Senior Associate at PricewaterhouseCoopers specializing in the pharmaceutical industry. Mr. Walfish was Manager of Non-Clinical Statistics at Chiron Diagnostics.
Mr. Walfish brings over 20 years of industrial expertise in the development and application of statistical methods for solving complex business issues including data collection, analysis and reporting.